Effect of flow rate on separation and peak symmetry. A 5 ml sample (1.4 mg/ml) of myoglobin (peak 1), ribonuclease A (peak 2), and cytochrome c (peak 3) was run on a 1 x 13 cm (8.7 ml) column at each of the indicated flow rates. The buffer was 20 mM potassium phosphate, pH 8.0, with a gradient of 0–1M KCl over 75 ml.

Virus validation with a model virus (or viruses) demonstrates to what extent a purification scheme is capable of reducing and/or removing viral particles that may be present in a cell line producing a biologic. Demonstrating potential virus inactivation and/or removal via the production process is recommended in the production of biologicals (US FDA 1993). The number and type of viruses used in a validation study depends upon many factors, including the type of cell line the product is from, and the intended use of the product (US FDA 1993). Virus validation is usually performed after a purification scheme has been developed and scaled up, so it is important to consider matrices that remove contaminating viruses (and nucleic acids in general) from the feed stream during the development of the purification. The ramifications of the chosen chromatographic steps should be evaluated for the positive implications on the virus validation study.

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